Z-0928-2026Class II

Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01

Name: Z-0928-2026 Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01
Creator: AVID Medical, Inc.
Published: 2025-11-14
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2025-11-14 / Open, Classified / root cause: manufacturing process

FDA source

AVID Medical, Inc. began a recall of Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01 on 2025-11-14. FDA classified it as Class II and gives the reason as "Potential for incomplete seal on header bag". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0928-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-14
Posted: 2025-12-15
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
Product: Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Product code: LRO General Surgery Tray
Reason for recall: Potential for incomplete seal on header bag.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.
Quantity in commerce: 300 units
Distribution: US distribution to GA, IL, NE, MD.
Product codes and lots: Catalog Number: EUHM009-01. UDI-DI: 10809160346839. Lot Number: 1635477. Expiration Date: 5/29/2028.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0928-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0926-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-15
Z-0927-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-15
Z-0928-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-15
Z-0929-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-15
Z-0930-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-15

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)